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In November 2006, the Venture Group fully acquired GES International Limited, augmenting Venture’s footprint as a leading ODM in the global Retail Store Solutions segment. In addition, the acquisition adds to the Venture Group’s overall competency and enhances the Group’s support to its customers for turnkey design and manufacturing services in the Retail Store Solutions and industrial products segment.Integrating the ODM activities of GES into the Group, Venture has significantly broadened t... Read More
|Address||5006 Ang Mo Kio Avenue 5, #05-01/12 TECHplace II Singapore 569873|
|Holding||No Holding Details|
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1) Quality Management System
a) Conduct internal audits for conformance to:
i) Quality Management System (QMS) – FDA 21 CFR Part 820, Part 11, cGMP, ISO 13485, and other applicable Medical Devices quality management system.
ii) Quality Plan pertaining to Device Master Record (DHR), Device History Record (DHR) and other requirements.
b) Develop audit plan and generate audit report.
c) Facilitate external certification and customers audits pertaining to QMS.
d) Conduct regular meeting to drive closure of audit findings.
e) Use the Corrective and Preventive Action Request tool to drive root cause determination and implement effective corrective / preventive actions.
2) Establishment Registration & Device Listing
a) Submit new /renewal application on the establishment registration and device listing for FDA and other countries regulatory requirements (e.g HSA, CE, etc ) according to customer specified requirements.
b) Assist QMS Manager in responding to complaints on adverse events or malfunctions that require reporting to a Governmental Authority accordingly to customers’ instruction.
3) Product Safety
a) Review product safety report and liaise with Factory QA/Engineering to identify critical safety parts for medical devices and life science products.
b) Conduct regular internal product safety audit.
c) Lead the product safety audit by product safety certification bodies on factory inspection
d) Co-ordinate with customers/RND and operation team to provide corrective action for any, nonconformance/findings during factory audit.
e) Conduct regular review of product safety procedure and revise whenever there is change in regulatory, customer and interal change.
4) Risk Management, Validation & Use of Quality Tools for Continual Improvement
a) Drive continual improvement activities with cross-functional teams through use of quality tools and techniques such as 7 simple QC Tools, FMEA, SPC,MSA, Control Plan, PPAP and track implementation of VMP for PCBA and Box Build Assembly processes.
5) Training (DL/Non-Exempt Staff)
a) Supervise and provide guidance on training material to Training Officer pertaining to direct staff /non-exempt staff training.
Education and Experience
- Degree /Diploma in an Engineering or Life Science discipline or related technical field
- Minimum 2 years experience in medical devices manufacturing industry.
- Strong knowledge of FDA 21 CFR 820, ISO 9001, ISO 13485.
- Working experience in the use of risk management tools such as FMEA and application on ISO 14971.
- Documentation Control, Electronic/Mechanical Components knowledge.
- Use of computer and Microsoft Excel and Words
- Good interaction skill
- Positive working attitude
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